Study Start Up Manager

Responsibilities:

• Excellent employment opportunity for a Study Start Up Manager (SSU M) in the Wilmington DE area.
• Remote (MUST be able to work EST time/hours)
• Responsible at country level for managing and conducting startup activities in compliance with the company procedures documents local and international guidelines such as ICH GCP and relevant regulations.
• The SSU Manager will prepare review track and manage site regulatory documentation at country and site level and will maintain review and report on site performance metrics.
• The SSU Manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study startup activities and milestones are achieved in a timely and efficient manner.
• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study startup and regulatory maintenance being in charge with collection preparation review and tracking of documents for the application process.
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during startup period.
• Actively participates in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as per required timelines during the startup period.
• Follow up on outstanding actions with study sites during startup period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP Company SOPs and local requirements.
• Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICHGCP prior to study start have been collected and verified for correctness prior to setting sites ready to enroll and in line with Company SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the startup period.

Experience:

• Bachelors Degree higher Degree Preferred.
• Excellent understanding of clinical trial process across Phases IIIV and ICH GCP
• Good understanding clinical protocols and associated study specifications.
• Minimum 3 years of current/recent Clinical Study Start Up Lead work ((must be their fulltime job not partial mix of maintenance or close out)
• Minimum 1 year of current/recent hands on Veena Vault Experience
• Successful candidates are expected to be study start up experts who lead/drive all aspects of startup and to be the main point of contact to sites.
• Minimum 3 years of Informed Consent Review and language negotiation with sites.
• Strong verbal & written communication skills
• Strong organization and Project Management skills
• Excellent understanding of clinical trial startup processes.
• Good vendor management skills
• Strong organizational skills with proven ability to handle multiple projects.
• Excellent communication presentation and interpersonal skills.
• Qualitydriven in all managed activities.
• Strong negotiating skills